Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Timed get up and go
Study Overview
Brief Summary
Stroke creats dependancy of patients due to various associated impairments. The use of low-cost technologies for neurological rehabilitation may be beneficial for the treatment of these patients.
Detailed Description
To determine the effectiveness of a structured protocol using semi-immersive virtual reality with commercial videogames for balance, postural control, functional independence, quality of life and motivation in patients who have suffered an ischemic and / or hemorrhagic stroke in subacute phase and are being treated in a mid-stay hospital.
Patients and methods: Randomized Controlled Trial. Simple blind. Control group will receive conventional therapy (physical therapy and occupational therapy) intervention being based on a task-oriented approach, with five weekly sessions of Physical Therapy and Occupational Therapy with duration of 45 minutes per session.
The experimental group will receive in addition to the above an experimental intervention during 8 weeks providing additional treatment using virtual reality semi-immersive complement is added by means of commercial video games implemented with the Xbox 360º video game console in conjunction with the Kinect device.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
All assessments will be made by blind evaluators with respect to the established study groups
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with CVA in subacute ischemic or hemorrhagic type.
- •NIHSS scale score less than
- •MoCA test with scores equal to or greater than 14 (mild cognitive impairment or absence of cognitive impairment).
- •Modified Rankin scale between 0-
- •Patients with the ability to maintain autonomous sitting and standing with or without aids.
- •Patients who have received the information document of the study and signed the informed consent form.
Exclusion Criteria
- •NIHSS scale scores greater than 21 .
- •MoCA test with score lower than
- •Modified Rankin scale between 5-
- •Patients without the ability to maintain autonomous sitting.
- •Patients who refused to sign the informed consent form.
- •Hospital discharge expected at the beginning of the study.
- •Patients who at any time have shown worsening of the general state, disinterest or desire to leave the study.
- •Pathologies susceptible to worsening or contraindication with virtual reality devices and commercial video games:
- •Photosensitive epilepsy.
- •Modified Ashworth scale greater than
- •Moderate-severe cognitive impairment.
- •Visual alterations.
- •Non-collaborating patient.
- •Behavioral alterations.
- •Refusal to treatment with VR systems.
- •Presence of other neurological pathologies.
- •Other cardiovascular diseases that contraindicate physical exercise.
- •Visual or auditory, musculoskeletal, bone or joint alterations in acute or chronic phase that could influence the primary pathology.
Arms & Interventions
Semi-immersive virtual reality
8 week protocol with semi-immersive virtual reality provided with the XBOX 360º video game console and its Kinect device. The commercial video games used will be: Kinect Sports I ®, Kinect Sport II ®, Kinect Joy Ride ® and Kinect Adventures ®.
Intervention: Semi-immersive virtual reality (Other)
Conventional Rehabilitation
Physical therapy and Occupational Therapy based on a task-oriented approach
Intervention: Conventional Rehabilitation (Other)
Outcomes
Primary Outcomes
Timed get up and go
Time Frame: eight weeks
It is a test used to evaluate functional mobility and balance, adapted and translated into Spanish. The patient must get up from a chair, walk three meters in a straight line, turn and return to sit in the chair. The valuation is quantified from 1 to 5: 1- normal, and 5- fall hazard during the test. At present study was conducted supervised by two people that were placed laterally to the patient.
Secondary Outcomes
- Static Posturography(eight weeks)
- Modified Rankin scale(eight weeks)
- Barthel index(eight weeks)
- Functional reach test(eight weeks)
- Baropodometry(eight weeks)
- Cano-Mañas scale(eight weeks)
- Tinetti scale(eight weeks)
- EQ-5D Questionnaire(eight weeks)